CE marking

Managing post-market maintenance

High introduction efforts (tools, infrastructure etc.)

Periodic updates of documentation compliance

Implementation of divers ongoing processes

«Decomplix» – The New Way

Get Simplified Market Access

Developers can start immediately with the CE certification. Decomplix brings compliance staff, a Notified Body and an ISO 13485 to the partnership. To stay in the market, Decomplix maintains the CE mark and stands at developers side.

We Invest in Developers CE Certification

The flat fees and guidance Decomplix offers makes the certification journey safe and calculable for you. You can choose a mix from four pricing options that suits you best. Decomplix invests in your CE certification in the pre-market phase.

CE Certification & CE Maintenance

After your onboarding, we review and complete the technical documentation, before submitting it to our Notified Body. With the CE mark your product gets market access and the maintenance phase begins. Decomplix is responsible towards end-users and authorities.

During the obtaining phase, you have to write the technical documentation because you know your product best. But don’t worry we’ll guide you. After entering the market, you have a reporting obligation & cooperation duty for resolution finding.

Joint Venture augmented

Decomplix AG was founded in June 2016 as a joint venture between established companies and professionals. The mission is to accelerate innovation by shortening the time-to-market and simplifying market access for medical devices. The founders are Hansjörg Riedwyl & Partner of the Medtech service provider ISS AG, the innovation agency Creaholic SA, the law firm Beutler Künzi Stutz AG and Beni Hirt from the app business. The multidisciplinary team has been augmented with two partners: netrics AG

As a leading swiss managed service provider and cloud pioneer, netrics AG provides IT services from its own data centers in Switzerland in combination with public cloud offers. Decomplix can connect its client’s medical apps and wearables with cloud services from secure data centers from the ISO 27001 certified netrics AG.